FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
114097–114120 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 07, 1993
L-CATH PEEL AWAY SYSTEM CATHETER
K920755 · LJS
Luther Medical Products, Inc.
General Hospital · 474d
Cleared Jun 07, 1993
SURGICAL DYNAMICS DISCOGRAPHY SYSTEM
K921950 · FMI
Surgical Dynamics, Inc.
General Hospital · 406d
Cleared Jun 07, 1993
HOSPITAL KIT SV 105
K922133 · LRO
Savoy Medical Supply Co., Inc.
General & Plastic Surgery · 397d
Cleared Jun 07, 1993
ENDOSNARE
K923031 · FDI
Cook Urological, Inc.
Gastroenterology & Urology · 349d
Cleared Jun 07, 1993
SUNGLASSES
K923778 · HQY
Cyrk Intl., Inc.
Ophthalmic · 314d
Cleared Jun 07, 1993
KEYSTONE CONCENTRATOR, MODEL PV5L
K924152 · CAW
Devilbiss Health Care, Inc.
Anesthesiology · 293d
Cleared Jun 07, 1993
NEW ULTRASOUND IMAGING SYSTEM & TRANSDUCERS
K924204 · IYN
Tetra Corp.
Radiology · 291d
Cleared Jun 07, 1993
BURTON H- BASE TABLE - MODEL 1990
K924773 · HRX
R.H. Burton Co.
Orthopedic · 257d
Cleared Jun 07, 1993
IRRIGATION TRAY W/ BULB SYRINGE
K924809 · KYZ
Customed, Inc.
General Hospital · 256d
Cleared Jun 07, 1993
PLEXUS PULSER I, PLEXUS PULSER II
K924891 · JOW
Dobre, Inc.
Cardiovascular · 252d
Cleared Jun 07, 1993
BIOPSY/MYELO/ARTHRO/AMNIOCENT/BASIC SKIN PREP TRAY
K924958 · KDD
Medical Insights, Inc.
General & Plastic Surgery · 250d
Cleared Jun 07, 1993
STERILE SUTURE REMOVAL KIT
K925015 · MCZ
Customed, Inc.
General & Plastic Surgery · 256d
Cleared Jun 07, 1993
TPN TRAY (STERILE)
K925021 · MCY
Customed, Inc.
General & Plastic Surgery · 256d
Cleared Jun 07, 1993
SARNS TURBO MEMBRANE OXYGENA. W/INT. RESERVOIR
K925075 · DTZ
3M Health Care, Sarns
Cardiovascular · 243d
Cleared Jun 07, 1993
SARNS TURBO MEMBRANE OXYGENA. W/INT. CARDIOTOMY R.
K925076 · DTZ
3M Health Care, Sarns
Cardiovascular · 243d
Cleared Jun 07, 1993
SCHNEIDER SOFTIP SST ANGIOGRAPHIC (DIAG) CATHETER
K926003 · DQO
Schneider Intl., Ltd.
Cardiovascular · 192d
Cleared Jun 07, 1993
PRO-PREP I.V. START/SCRUB-PREP/BLOOD CULTURE KIT
K926031 · LRS
Brigam Medical, Inc.
General & Plastic Surgery · 188d
Cleared Jun 07, 1993
PER-Q-CATH DRESSING CHANGE TRAY
K926063 · MCY
Gesco Intl., Inc.
General & Plastic Surgery · 188d
Cleared Jun 07, 1993
FLUID DRAINAGE TRAY
K926109 · GBX
Symbiosis Corp.
General & Plastic Surgery · 186d
Cleared Jun 07, 1993
OPUS MAGNUM ANALYZER
K926131 · KHO
Pb Diagnostic Systems, Inc.
Chemistry · 182d
Cleared Jun 07, 1993
SCHNEIDER MATCH-35 PERCUTANEOUS TRANSLUMINAL ANGIO
K926271 · LIT
Schneider Intl., Ltd.
Cardiovascular · 171d
Cleared Jun 07, 1993
UC QIK PREGNANCY TEST
K926500 · JHI
Eucardio Laboratory, Inc.
Chemistry · 160d
Cleared Jun 07, 1993
ACCESS THYROID UPTAKE ASSAY
K930010 · CEE
Bio-Rad Laboratories, Inc.
Chemistry · 154d
Cleared Jun 07, 1993
ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATOR
K930477 · JIS
Analytical Control Systems, Inc.
Chemistry · 129d